Remote catheter procedure system

ABSTRACT

A catheter procedure system including a bedside system and a remote workstation is provided. The bedside system includes a catheter including an expandable percutaneous intervention device, a robotic catheter system configured to move the catheter, and an inflation device configured to cause expansion of the expandable percutaneous intervention device. The remote workstation includes a user interface configured to receive a at least first user input and a second user input and a control system operatively coupled to the user interface for remotely controlling both the robotic catheter system and the inflation device. The remote workstation includes a monitor configured to display information related to the expandable percutaneous intervention device. The control system controls the robotic catheter system to move the catheter based upon at least the first user input and controls the inflation device to cause expansion of the expandable percutaneous intervention device based upon at least the second user input.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/372,985, filed Dec. 8, 2016, titled REMOTE CDATHETER PROCEDURESYSTEM, which is a continuation of U.S. application Ser. No. 13/152,168,filed Jun. 2, 2011, titled REMOTE CATHETER PROCEDURE SYSTEM, which is acontinuation of PCT/US2009/067540, filed on Dec. 10, 2009, which claimsthe benefit of U.S. Provisional Application No. 61/122,263, filed Dec.12, 2008, all of which are incorporated herein by reference in theirentirety.

BACKGROUND OF THE INVENTION

The present invention relates generally to the field of catheter systemsfor performing diagnostic and/or therapeutic procedures. The presentinvention relates specifically to catheter systems including a userinterface and/or workstation for controlling a robotic catheter system,an inflation device for the inflation of an angioplasty balloon and/orstent, a contrast media delivery device, and/or other related systems.

Vascular disease, and in particular cardiovascular disease, may betreated in a variety of ways. Surgery, such as cardiac bypass surgery,is one method for treating cardiovascular disease. However, undercertain circumstances, vascular disease may be treated with a catheterbased therapeutic procedure, such as angioplasty or stent placement.Catheter based therapeutic procedures are generally considered lessinvasive than surgery. If a patient shows symptoms indicative ofcardiovascular disease, an image of the patient's heart may be taken toaid in the diagnosis of the patient's disease and to determine anappropriate course of treatment. For certain disease types, such asatherosclerosis, the image of the patient's heart may show a lesion thatis blocking one or more coronary arteries. Following the diagnosticprocedure, the patient may undergo a catheter based therapeuticprocedure. During one type of therapeutic procedure, a catheter isinserted into the patient's femoral artery and moved through thepatient's arterial system until the catheter reaches the site of thelesion. In some procedures, the catheter is equipped with a balloon or astent that when deployed at the site of a lesion allows for increasedblood flow through the portion of the coronary artery that is affectedby the lesion. In addition to cardiovascular disease, other diseases maybe treated with catheterization procedures.

SUMMARY OF THE INVENTION

On embodiment of the invention relates to a catheter procedure system.The catheter procedure system includes a bedside system. The bedsidesystem includes a catheter including an expandable percutaneousintervention device, a robotic catheter system configured to move thecatheter, and an inflation device configured to cause expansion of theexpandable percutaneous intervention device. The catheter proceduresystem also includes a remote workstation. The remote workstationincludes a user interface configured to receive at least a first userinput and a second user input and a control system operatively coupledto the user interface for remotely controlling both the robotic cathetersystem and the inflation device. The remote workstation includes amonitor configured to display information related to the expandablepercutaneous intervention device. The control system controls therobotic catheter system to move the catheter based upon at least thefirst user input and controls the inflation device to cause expansion ofthe expandable percutaneous intervention device based upon at least thesecond user input.

Another embodiment of the invention relates to a remote workstationconfigured for operating both a robotic catheter system and an inflationdevice. The remote workstation includes a user interface configured toreceive at least a first user input and a second user input. The remoteworkstation includes a control system to control the robotic cathetersystem to move at least one percutaneous device based upon at least thefirst user input and to control the inflation device to expand anexpandable percutaneous intervention device based upon at least thesecond user input. The remote workstation also includes a userassistance subsystem operatively connected to the control systemconfigured to provide information to the user to assist the user in theuse of the expandable percutaneous intervention device.

Another embodiment of the invention relates to a catheter proceduresystem including a bedside system and a remote workstation. The bedsidesystem includes a catheter, the catheter including an internal lumen andan expandable percutaneous intervention device. The bedside system alsoincludes a support structure configured to be coupled to a patient bed,a robotic catheter system coupled to the support structure andconfigured to move the catheter, an inflation device coupled to thesupport structure and configured to cause expansion of the expandablepercutaneous intervention device, and an inflation conduit connectingthe inflation device to the internal lumen of the catheter. The remoteworkstation includes a monitor, controls configured to receive at leasta first user input and at least a second user input, and a controlsystem operatively coupled to the user interface for remotelycontrolling both the robotic catheter system and the inflation device.The control system controls the robotic catheter system to move thecatheter based upon at least the first user input and controls theinflation device to cause a fluid to flow from the inflation devicethrough the inflation conduit into the lumen of the catheter to causeexpansion of the expandable percutaneous intervention device based uponat least the second user input, and the monitor displays informationrelated to both the robotic catheter system and the inflation device.

BRIEF DESCRIPTION OF THE DRAWINGS

This application will become more fully understood from the followingdetailed description, taken in conjunction with the accompanyingfigures, wherein like reference numerals refer to like elements inwhich:

FIG. 1 is a perspective view of a catheter procedure system according toan exemplary embodiment;

FIG. 2 is a block diagram of a catheter procedure system according to anexemplary embodiment;

FIG. 3 is a block diagram of a control system according to an exemplaryembodiment;

FIG. 4A is a perspective view of a bedside system according to anexemplary embodiment;

FIG. 4B is a close up view of a bedside system according to an exemplaryembodiment;

FIG. 5 is a perspective view of a catheter procedure system according toanother exemplary embodiment;

FIG. 6 is a block diagram of the catheter procedure system shown in FIG.5 according to an exemplary embodiment;

FIG. 7 is a block diagram of a catheter control system according to anexemplary embodiment;

FIG. 8 is a block diagram of a contrast media delivery device controlsystem according to an exemplary embodiment;

FIG. 9 is a block diagram of an inflation device control systemaccording to an exemplary embodiment;

FIG. 10 is a block diagram of a catheter procedure system having acommunication hub according to an exemplary embodiment;

FIG. 11 is a perspective view of a catheter procedure system accordingto another exemplary embodiment;

FIG. 12 is a block diagram of the catheter procedure system shown inFIG. 11 according to an exemplary embodiment;

FIG. 13 is a block diagram of a control system according to an exemplaryembodiment;

FIG. 14 is a block diagram of a catheter procedure system according toanother exemplary embodiment; and

FIG. 15 is a block diagram of a catheter procedure system according toanother exemplary embodiment.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1, a catheter procedure system 10 is shown. Catheterprocedure system 10 may be used to perform catheter based medicalprocedures (e.g., percutaneous intervention procedures). Percutaneousintervention procedures may include diagnostic catheterizationprocedures during which one or more catheters are used to aid in thediagnosis of a patient's disease. Percutaneous intervention proceduresmay also include catheter based therapeutic procedures (e.g.,angioplasty, stent placement, treatment of peripheral vascular disease,etc.) during which a catheter is used to treat a disease. During bothdiagnostic and therapeutic procedures, images of a patient's heart maybe captured using a medical imaging device. During such procedures,contrast media may be injected into the patient's vascular system to aidin image capture. It should be noted, however, that one skilled in theart would recognize that, certain specific percutaneous interventiondevices or components (e.g., type of guide wire, type of catheter, etc.)will be selected based on the type of procedure that is to be preformed.Catheter procedure system 10 is capable of performing any number ofcatheter based medical procedures with minor adjustments to accommodatethe specific percutaneous intervention devices to be used in theprocedure. In particular, while the embodiments of catheter proceduresystem 10 described herein are explained primarily in relation to thediagnosis and/or treatment of coronary disease, catheter proceduresystem 10 may be used to diagnose and/or treat any type of disease orcondition amenable to diagnosis and/or treatment via a catheter basedprocedure.

In one embodiment, catheter procedure system 10 may be equipped toperform a catheter based diagnostic procedure. In this embodiment,catheter procedure system 10 may be equipped with a variety of cathetersfor the delivery of contrast media to the coronary arteries. In oneembodiment, catheter procedure system 10 may be equipped with a firstcatheter shaped to deliver contrast media to the coronary arteries onthe left side of the heart, a second catheter shaped to deliver contrastmedia to the coronary arteries on the right side of the heart, and athird catheter shaped to deliver contrast media into the chambers of theheart.

In another embodiment, catheter procedure system 10 may be equipped toperform a catheter based therapeutic procedure. In this embodiment,catheter procedure system 10 may be equipped with a guide catheter, aguide wire, and a working catheter (e.g., a balloon catheter, a stentdelivery catheter, etc.). During certain therapeutic procedures anexpandable percutaneous device (e.g., an angioplasty balloon, stent,etc.) may be positioned near one end of the working catheter. Theworking catheter is navigated through a patient's vascular system toposition the expandable percutaneous device at a portion of a bloodvessel that has been narrowed due to a lesion caused by a disease, suchas atherosclerosis. The expandable percutaneous device is expanded atthe narrowed portion to increase the diameter of the blood vessel lumenat the lesion. This expansion allows for increased blood flow throughthat portion of the blood vessel. In the case of balloon angioplasty,the expandable device is an angioplasty balloon that is expanded bybeing inflated to compress the material of the lesion which increasesthe diameter of the blood vessel. In the case of stent placement, astent is expanded and left inside the blood vessel at the site of alesion to increase the diameter of the blood vessel. In one stentplacement technique, a balloon (e.g., a balloon configured to deploy astent) is positioned in the middle of the stent, and the expansion ofthe balloon expands the stent.

Catheter procedure system 10 includes a lab unit 12 and a remoteworkstation 14. Catheter procedure system 10 includes an integratedbedside system 310 coupled to support structure 24 located within labunit 12 adjacent patient 18. Bedside system 310 includes a roboticcatheter system 17 and an inflation device 22. Integrated bedside system310 may include a single power supply to power both robotic cathetersystem 17 and an inflation device 22. In addition, integrated bedsidesystem 310 may include a single communication link to communicablycouple both robotic catheter system 17 and inflation device 22 tocontroller 340.

Generally, robotic catheter system 17 may be equipped with theappropriate percutaneous intervention devices or components (e.g., guidewires, guide catheters, working catheters, catheter balloons, stents,medicine, diagnostic catheters, etc.) to allow the user to perform acatheter based medical procedure. Robotic catheter system 17 may be anysystem configured to allow a user to interact with (e.g., move,manipulate, control, etc.) percutaneous intervention devices via arobotic system by operating various controls such as the controlslocated at workstation 14. Robotic catheter system 17 may include anynumber and/or combination of components to provide robotic cathetersystem 17 with the functionality described herein. One embodiment ofrobotic catheter system 17 is described in International Application No.PCT/US2009/042720, filed May 4, 2009, which is incorporated herein byreference in its entirety.

Inflation device 22 of bedside system 310 may be any device configuredto allow a user to expand an expandable percutaneous intervention device(e.g., to inflate an angioplasty balloon or a balloon configured todeploy a stent during a therapeutic catheterization procedure).Inflation conduit 34 connects inflation device 22 to one or moreexpandable percutaneous devices, such as an angioplasty balloon orstent, that bedside system 310 is equipped with. In one embodiment,inflation conduit 34 is connected to an input end of a working catheter.The working catheter has an internal lumen that allows fluid to bepumped from inflation device 22 through inflation conduit 34 into thelumen of the working catheter to inflate a balloon located at the distalend of the working catheter. Inflation device 22 includes variouscomponents (e.g., pumps, valves, power supplies, inflation mediareservoir, etc.) to allow a balloon to be inflated in response to theoperation of controls operatively connected to inflation device 22. Thisballoon may be an angioplasty balloon or a stent delivery balloon. Whilethe disclosure here relates primarily to angioplasty balloons and/orstents expanded by the expansion of a balloon, any other expandablepercutaneous intervention device (e.g., shape memory alloy stents, etc.)may be used.

In one embodiment, bedside system 310 is in communication withworkstation 14, allowing signals generated by user inputs located atworkstation 14 to be transmitted to bedside system 310 to control thefunctions of robotic catheter system 17 and inflation device 22. Bedsidesystem 310 may provide feedback signals (e.g., operating conditions,warning signals, error codes, etc.) to workstation 14. Bedside system310 may be connected to workstation 14 via one or more communicationlink 38 that may be a wireless connection, cable connector, or any othermeans capable of allowing communication to occur between workstation 14and the devices or systems located within lab unit 12.

In the embodiment shown in FIG. 1, workstation 14 includes a userinterface 300. User interface 300 is positioned on work table 36 withinworkstation 14. As shown in FIG. 1, workstation 14 is a remoteworkstation located, for example, in either a procedure room or aseparate control room. In one embodiment, a transparent protectivescreen or shield (e.g., leaded glass, etc.) may be positioned betweenworkstation 14 and lab unit 12 to shield the user at workstation 14 fromradiation generated within lab unit 12 (e.g., by imagining system 60).Workstation 14 may be located at any place within a hospital.Workstation 14 may also be located at any location outside of thehospital, such as in a physician's offsite office, mobile workstationtrailer, etc. Lab unit 12 may include a video camera so that the user atworkstation 14 is able to see patient 18 within lab unit 12 whenworkstation 14 is located such that direct visual inspection of lab unit12 is not possible.

User interface 300 includes controls 302. Controls 302 allow the user tocontrol bedside system 310 to perform a catheter based medicalprocedure. For example, controls 302 may be configured to cause roboticcatheter system 17 to perform various tasks using the variouspercutaneous intervention devices with which bedside system 310 may beequipped (e.g., to advance, retract, or rotate a guide wire, advance,retract, or rotate a working catheter, advance, retract, or rotate aguide catheter, advance, retract, or rotate a diagnostic catheter,etc.). Various embodiments of user interface 300 are described in detailin International Application No. PCT/US2009/55320, filed Aug. 28, 2009,and International Application No. PCT/US2009/55318, filed Aug. 28, 2009,both of which are incorporated herein by reference in their entireties.

In addition, controls 302 allow a user to cause an angioplasty balloonor a stent placement balloon to be inflated and deflated by controllinginflation device 22. Controls 302 include one or more buttons orjoysticks that allow the user located at workstation 14 to instructinflation device 22 to inflate (e.g., expand, deploy, etc.) and/ordeflate an expandable percutaneous intervention device, such as a stentor angioplasty balloon, during a percutaneous procedure. Controls 302may be configured to allow the user to control various aspects ofballoon or stent inflation and/or deflation (e.g., rate of inflation,extent of inflation, amount of time the balloon or stent remainsinflated, pressure generated by inflation device 22, etc.). In oneembodiment, controls 302 may include one input device (e.g., a button,knob, touch screen, etc.) that causes inflation, and a second inputdevice (e.g., a button, knob, touch screen, etc.) to allow the user toset the rate of inflation and/or maximum inflation size or pressure. Inone embodiment, operation of controls 302 activates a motor or pump ofinflation device 22 to pump inflation fluid (e.g., saline solution,saline and contrast media mixture, etc.) from a fluid reservoir throughinflation conduit 34 into the internal lumen of a working catheter togenerate pressure that results in the expansion of an angioplastyballoon or a stent.

User interface 300 may include a first monitor 304 and a second monitor306. First monitor 304 and a second monitor 306 may be configured todisplay information to the user located at workstation 14. For example,first monitor 304 and a second monitor 306 may be configured to displayimage data (e.g., x-ray images, MRI images, CT images, ultrasoundimages, etc.), hemodynamic data (e.g., blood pressure, heart rate,etc.), patient record information (e.g., medical history, age, weight,etc.). In addition, first monitor 304 and a second monitor 306 may beconfigured to display other information (e.g., duration of procedure,catheter or guide wire position, volume of medicine or contrast mediadelivered, extent of inflation of an expandable percutaneous device,etc.). Further, monitor 304 and second monitor 306 may be configured todisplay information to provide the functionalities associated with thevarious modules of controller 340 discussed below or with the variousmodules disclosed in the incorporated references.

Monitors 304 and/or 306 may be configured to provide various informationto the user of workstation 14 regarding an expandable percutaneousintervention device. For example, monitors 304 and/or 306 may display animage of the balloon or stent within the patient, an indication ofwhether bedside system 310 is currently equipped with an angioplastyballoon or a stent (e.g., a graphic represent the current device, etc.),information about the type of device being used (e.g., the size, shape,manufacturer, etc.), information about the extent of inflation of theballoon or stent, the duration of inflation, the amount of force beingexerted on the balloon or stent by the vessel wall, the fluid pressurewithin the balloon generated by inflation system 22, etc.

Catheter procedure system 10 also includes an imaging system 60 locatedwithin lab unit 12. Imaging system 60 may be any medical imaging systemthat may be used in conjunction with a catheter based medical procedure(e.g., non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.). Inan exemplary embodiment, imaging system 60 is a digital x-ray imagingdevice that is in communication with workstation 14. As shown in FIG. 1,imaging system 60 may include a C-arm that allows imaging system 60 topartially or completely rotate around patient 18 in order to obtainimages at different angular positions relative to patient 18 (e.g.,sagital views, caudal views, cranio-caudal views, etc.).

Imaging system 60 is configured to take x-ray images of the appropriatearea of patient 18 during a particular procedure. For example, imagingsystem 60 may be configured to take one or more x-ray images of theheart to diagnose a heart condition. Imaging system 60 may also beconfigured to take one or more x-ray images during a catheter basedmedical procedure (e.g., real-time images) to assist the user ofworkstation 14 to properly position a guide wire, catheter, angioplastyballoon, stent, etc. during the procedure. The image or images may bedisplayed on first monitor 304 and/or second monitor 306. In addition,the user of workstation 14 may be able to control the angular positionof imaging system 60 relative to the patient to obtain and displayvarious views of the patient's heart on first monitor 304 and/or secondmonitor 306. Displaying different views at different portions of theprocedure may aid the user of workstation 14 to properly move andposition the percutaneous intervention devices within the 3D geometry ofthe patient's heart. In an exemplary embodiment, imaging system 60 maybe any 3D imaging modality of the past, present, or future, such as anx-ray based computed tomography (CT) imaging device, a magneticresonance imaging device, a 3D ultrasound imaging device, etc. In thisembodiment, the image of the patient's heart that is displayed during aprocedure may be a 3D image. In addition, controls 302 may also beconfigured to allow the user positioned at workstation 14 to controlvarious functions of imaging system 60 (e.g., image capture,magnification, collimation, c-arm positioning, etc.).

Referring to FIG. 2, a block diagram of catheter procedure system 10 isshown according to an exemplary embodiment. Catheter procedure system 10includes a control system, shown as controller 340. As shown in FIG. 2,controller 340 may be part of workstation 14. Controller 340 is incommunication with one or more bedside systems 310, controls 302,monitors 304 and 306, imaging system 60, and patient sensors 68 (e.g.,electrocardiogram (“ECG”) devices, electroencephalogram (“EEG”) devices,blood pressure monitors, temperature monitors, heart rate monitors,respiratory monitors, etc.). In addition, controller 340 may be incommunication with a hospital data management system or hospital network70, one or more additional output devices 72 (e.g., printer, disk drive,cd/dvd writer, etc.), and a hospital inventory management system 74.

Communication between the various components of catheter proceduresystem 10 may be accomplished via communication links 38. Communicationlinks 38 may be dedicated wires or wireless connections. Communicationlinks 38 may also represent communication over a network. Catheterprocedure system 10 may be connected to or configured to include anyother systems and/or devices not explicitly shown. For example, catheterprocedure system 10 may include intravenous ultrasound systems (“IVUSsystems”), image processing engines, data storage and archive systems,contrast media and/or medicine injection systems, medicine trackingand/or logging systems, user logs, encryption systems, systems torestrict access or use of catheter procedure system 10, robotic cathetersystems of the past, present, or future, etc.

Referring to FIG. 3, a block diagram of controller 340 is shownaccording to an exemplary embodiment. Controller 340 may generally be anelectronic control unit suitable to provide catheter procedure system 10with the various functionalities described herein. For example,controller 340 may be an embedded system, dedicated circuit, generalpurpose system programmed with the functionality described herein, etc.

Controller 340 includes a processing circuit 342, memory 344,communication module or subsystem 346, communication interface 348, arobotic catheter system control module or subsystem 350, an inflationdevice control module 352, a data storage module 354, and anidentification and compatibility module 356. Controller 340 may includeadditional modules or subsystems or combinations of modules orsubsystems described herein and/or described in detail in InternationalApplication No. PCT/US2009/55320, filed Aug. 28, 2009, and InternationalApplication No. PCT/US2009/55318, filed Aug. 28, 2009, both of which areincorporated herein by reference in their entireties.

Processing circuits described herein, such as processing circuit 342,may be general purpose processors, application specific processors(ASICs), circuits containing one or more processing components, groupsof distributed processing components, groups of distributed computersconfigured for processing, etc. configured to provide the functionalityof module or subsystem components discussed herein. Memory unitsdescribed herein, such as memory unit 344 (e.g., memory device, storagedevice, etc.), may be one or more devices for storing data and/orcomputer code for completing and/or facilitating the various processesdescribed in the present disclosure. Memory units described herein mayinclude volatile memory and/or non-volatile memory. Memory unitsdescribed herein may include database components, object codecomponents, script components, and/or any other type of informationstructure for supporting the various activities described in the presentdisclosure.

According to an exemplary embodiment, any distributed and/or localmemory device of the past, present, or future may be utilized with thesystems and methods of this disclosure. According to an exemplaryembodiment, memory units described herein (e.g., memory unit 344) arecommunicably connected to one or more associated processing circuit(e.g., processing circuit 342). This connection may be via a circuit orany other wired, wireless, or network connection and includes computercode for executing one or more processes described herein. A singlememory unit may include a variety of individual memory devices, chips,disks, and/or other storage structures or systems.

Module or subsystem components discussed herein may be computer code(e.g., object code, program code, compiled code, script code, executablecode, or any combination thereof) for conducting each module'srespective functions. Module or subsystem components discussed hereinmay be stored in one or more local, distributed, and/or remote memoryunits (e.g., memory unit 344) configured to be in communication with oneor more processing circuits (e.g., processing circuit 342) or anothersuitable processing system.

Communication interfaces discussed herein, such as communicationinterface 348, include one or more component for communicably couplingthe associated controller (e.g., controller 340) to the other componentsof catheter procedure system 10 via communication links 38.Communication interfaces may include one or more jacks or other hardwarefor physically coupling communication links 38 to one or morecontroller, an analog to digital converter, a digital to analogconverter, signal processing circuitry, and/or other suitablecomponents. Communication interfaces may include hardware configured toconnect one or more controller with the other components of catheterprocedure system 10 via wireless connections. Communication modulesdiscussed herein, such as communication module 346, are configured tosupport the communication activities of the associated controller (e.g.,negotiating connections, communication via standard or proprietaryprotocols, etc.).

Controller 340 includes a robotic catheter system control module 350configured to support the control of robotic catheter system 17 during acatheter based medical procedure. Robotic catheter system control module350 allows the manipulation of controls 302 by the user to operaterobotic catheter system 17 (e.g., to advance, retract, or rotate a guidewire, advance, retract, or rotate a working catheter, advance, retract,or rotate a guide catheter, advance, retract, or rotate a diagnosticcatheter, etc.). Robotic catheter system control module 350 may alsocause data appropriate for a particular procedure to be displayed onmonitors 304 and/or 306. Robotic catheter system control module 350 mayinclude sets of instructions specific to various types of catheter basedprocedures that may be performed using robotic catheter system 17. Forexample, robotic catheter system control module 350 may include one setof instructions that will be executed by processing circuit 342 ifrobotic catheter system 17 is being used to perform a diagnosticcatheterization procedure and another set of instructions that will beexecuted by processing circuit 342 if robotic catheter system 17 isbeing used to perform an therapeutic catheter procedure. In addition,controller 340 may also include a module to allow a user located atworkstation 14 to operate imaging system 60 via manipulation of controls302.

Inflation device control module 352 is configured to support the controlof inflation device 22 during a catheter based medical procedure.Inflation device control module 352 allows manipulation of controls 302by the user to operate inflation device 22 (e.g., inflation of anangioplasty balloon or stent, deflation of an angioplasty balloon orstent, etc.). Inflation device control module 352 may include separatesets of instructions to be executed for each expandable device that maybe used with bedside system 310. For example, inflation device controlmodule 352 may include one set of instructions to be executed byprocessing circuit 342 if bedside system 310 is equipped with anangioplasty balloon and another set of instructions to be executed byprocessing circuit 342 if bedside system 310 is equipped with a stent.

Controller 340 may include a user assistance module 358. In general,user assistance module 358 includes software and/or hardware configuredto assist the user to perform various tasks using catheter proceduresystem 10. In another embodiment, user assistance module 358 may provideassistance by altering the response of inflation device 22 in responseto the manipulation of controls 302 to provide for improved or optimizedinflation of an expandable device (e.g., an angioplasty balloon or astent) based on data accessible to controller 340. In other embodiments,user assistance module 358 may automate control of various components ofcatheter procedure system 10, such as inflation of an inflatable device.In another embodiment, user assistance module 358 may be configured toprovide assistance to the user regarding the control of a fluid deliverydevice, such as contrast media delivery device 20, discussed below.

In one embodiment, user assistance module 358 may be configured to helpprevent damage to the endothelium of the blood vessel that may be causedby the movement of the percutaneous devices within the vessel. Forexample, user assistance module 358 may be configured to smooth themovement of a percutaneous device (e.g., catheter, guide wire, etc.) inresponse to a user's manipulation of controls 302 by filtering outsignals that would result in movement of the percutaneous device that isabove a certain threshold. Similarly, user assistance module 358 maylimit inflation of an angioplasty balloon or stent by ensuring that therate of expansion does not exceed a maximum threshold. In theseembodiments, robotic catheter system control module 350 and/or inflationdevice control module 352 may be configured to allow the user to togglethis protective feature on and off.

In another embodiment, user assistance module 358 is configured toautomatically inflate an inflatable device at a certain rate and to acertain pressure to provide for the best clinical results. For example,user assistance module 358 may utilize image data generated by imagingsystem 60 to measure the size of a lesion and/or to identify the type ofthe lesion (e.g., a soft lesion, or a calcified lesion, etc.). This datais then used to automatically expand the inflatable device to a certainpressure at a certain rate based upon the identified characteristics ofthe lesion. In one embodiment, imaging system 60 includes an intravenousultrasound system (“IVUS”), and user assistance module 358 includes aset of inflation profiles (e.g., pressure vs. time profiles, diametervs. time profiles, etc.) to be used to treat different types of lesions.User assistance module 358 identifies which inflation profile is optimalfor treatment of a particular lesion based upon the IVUS image data. Inthis embodiment, user assistance module 358 automatically inflates theinflatable device utilizing the inflation profile determined to beoptimal to treat the particular lesion. In another embodiment, theinflation profile to be used may be selected by the user. In oneembodiment, user assistance module 358 may be configured to alert (e.g.,through display of an icon, audible alarm, etc.) a user that theinflatable device has been expanded to the predetermined value (e.g.,size, pressure, etc.). In another embodiment, user assistance module 358may be configured to alert (e.g., through display of an icon, audiblealarm, etc.) a user that the amount of fluid (e.g., contrast media,medicine, etc.) delivered via control of a fluid delivery device, suchas contrast media delivery device 20, has reached a predetermined value(e.g., volume, rate, etc.).

In another embodiment, user assistance module 358 may suggest thepositioning of the inflatable device relative to the lesion to achievebetter or optimal clinical results. In one embodiment, monitor 304and/or 306 may display a real time image of the portion of the bloodvessel containing the lesion. In this embodiment, user assistance module358 may display a landmark over the real time image to indicate theoptimal positioning of the inflatable device relative to the lesion asdetermined by user assistance module 358. The operator may align theimage of the inflatable device with the landmark in the real time imageto ensure proper positioning of the inflatable device.

In another embodiment, user assistance module 358 may be configured toensure that the position of the inflatable device relative to the lesionremains substantially unchanged during the inflation procedure. In thisembodiment, user assistance module 358 identifies a landmark (e.g., thedesired position of the center point of the inflatable device relativeto the lesion). In one embodiment, the landmark is selected by the userby identifying the landmark on the real time image of the blood vessel(e.g., by clicking on a portion of the image with a mouse, touching theportion of the image displayed on a touch-sensitive display, etc.). Inanother embodiment, the landmark is automatically determined by userassistance module 358. In this embodiment, user assistance module 358may detect motion of the inflatable device relative the lesion.Detection of the relative motion may be done by analyzing the real timeimage of the inflatable device and the lesion and/or by positionalsensors positioned in the inflatable device. If motion is detected, userassistance module 358 may automatically advance or retract the catheterequipped the inflatable device to realign a target point located alongthe inflatable device with the landmark of the lesion. Inflation of theinflatable device is allowed to proceed following the realignment of theinflatable device with the landmark. In another embodiment, userassistance module 358 may alter (e.g., decrease rate of expansion,increase rate of expansion, etc.) the expansion of the inflatable devicebased upon the position of the one of the other percutaneous devices(e.g., guide wire, guide catheter, etc.) in order to synchronize theexpansion of the inflatable device with movement of one of the otherpercutaneous devices. In another embodiment, the user assistance module358 of the control system is configured to cause or trigger expansion ofthe inflatable device when the target point is aligned with the landmarkand to prevent, slow, or stop expansion of the inflatable device whenthe target point of the inflatable device is not aligned with thelandmark.

In another embodiment, user assistance module 358 may delay and/oraccelerate the inflation of an inflatable device based on data relatedto the state of heart contraction (e.g., based on whether the heart isundergoing systole or diastole). This data may be obtained fromelectrocardiogram data generated by patient sensors 68, from image data,or from any other information source. In one embodiment, if the usermanipulates controls 302 to trigger inflation of the inflatable deviceduring systole, user assistance module 358 will delay the inflation ofballoon or stent so that the balloon or stent actually inflates duringdiastole. In another embodiment, user assistance module 358 may beconfigured to alter the delivery of a fluid, such as contrast media,caused by operation of a fluid delivery device, such as contrast mediadelivery device 20, such that the fluid is delivered during the systolicphase of the patient's heart. In one embodiment, user assistance module258 may delay and/or accelerate delivery of the fluid in response to auser input to ensure that the fluid is delivered during the desiredstage of heart contraction.

In another embodiment, user assistance module 358 may be configured toprovide suggestions to the user that are displayed on monitors 304and/or 306 regarding the performance of various steps of the procedure.For example, user assistance module 358 may suggest the pressure to beused to inflate a particular inflatable device based upon variousinformation (e.g., the particular lesion being treated, the geometry ofparticular patient's vessel, etc.). User assistance module 358 maysuggest an inflation rate to be used to inflate a particular inflatabledevice based upon various information (e.g., the particular lesion beingtreated, the geometry of particular patient's vessel, etc.). Thisembodiment allows the user to decide whether to follow the suggestiongenerated by user assistance module 358 or to preform the procedure inanother way.

In another embodiment, user assistance module 358 may improve, optimize,or automate the control of imaging system 60. In one embodiment,controller 340 automatically alters the angular position of the imagingsystem 60 relative to the patient to obtain an image of the lesion. Inanother embodiment, contrast media is injected, images of the lesion aretaken, and the inflatable device is inflated based on the state ofcontraction of the patient's heart. In another embodiment, images of theinflation procedure are taken timed to various steps of the procedure.This may reduce the radiation dose and amount of contrast media used byonly taking images during the most relevant portions of the inflationprocedure as contrasted with constantly imaging the patient during thewhole procedure. For example, user assistance module 358 may beconfigured to automatically image the area of the lesion and theinflatable device when the device is at one percent inflation, fiftypercent inflation, and one hundred percent inflation. In anotherembodiment, user assistance module 358 may be configured to alter (e.g.,delay, or accelerate) control, in response to a user input, of a fluiddelivery device, such as contrast media delivery device 20, based uponthe movement of the at least one percutaneous device in order tosynchronize the delivery of the fluid with the movement of thepercutaneous device. For example, contrast media may be deliveredimmediately prior to movement of a percutaneous device to ensure animage of taken during movement of the percutaneous device has maximumresolution. In one embodiment, delivery of the contrast agent may be inresponse to the user input indicating movement of the percutaneousdevice to ensure the movement of the device is accompanied by a newinjection of contrast media.

In another embodiment, user assistance module 358 is configured toprovide suggestions or recommendations regarding the particular type(e.g., compliant angioplasty balloon, noncompliant angioplasty balloon,stent, etc.), make, model, size, etc., of inflatable device to be usedfor a particular procedure. The suggestion may be based upon the size,geometry, and type of lesion, and/or the size and geometry of the bloodvessel. This information may be derived from image data of the lesionobtained during a diagnostic catheterization procedure or any otherimaging procedure. In other embodiments, the suggestion regarding thetype of inflatable device may factor in the personal preferences of auser, and/or may be based in part on the performance of a simulatedtherapeutic procedure.

As discussed above, controller 340 may be in communication with hospitalinventory system 74. In one embodiment, the suggestion regarding thetype of inflatable device made by user assistance module 358 may bebased upon whether particular devices are available in the hospital'sinventory at the time of the procedure. In another embodiment, userassistance module 358 may be configured to automatically order thesuggested inflatable device so that the suggested inflatable device isavailable to the user at the time of the procedure.

Inflation device control module 352 may also cause data appropriate fora particular procedure to be displayed on monitors 304 and/or 306 duringa procedure. In one embodiment, inflation device control module 352 isconfigured to cause the display of information related to the state ofinflation of the angioplasty balloon or stent caused by the inflationdevice 22. In one embodiment, the display is a digital or analog gaugedisplaying the pressure generated by inflation device 22. This displaymay show pressure in any unit of pressure measurement (e.g.,atmospheres, pascal, pounds per square inch, bar, etc.). In anotherembodiment, the display may show an image of the angioplasty balloon orstent at various stages of expansion.

In another embodiment, inflation device control module 352 may causevarious information regarding the angioplasty balloon or stent that isbeing used to display on monitors 304 and/or 306. Information displayedmay include information regarding the make, model, size, suggested uses,recommended operating conditions, etc. for angioplasty balloons orstents that may be used with bedside system 310. In one embodiment, thedisplay may show the manufacturer's recommended maximum inflationpressure to be used with a particular inflatable device. Fornon-compliant balloons the display may indicate the size of the balloonfollowing inflation. For compliant balloons, the display may indicatethe size of the balloon for various pressures. In another embodiment,the display may provide a graph (e.g., a bar graph, a pie graph, etc.)showing the current pressure supplied by inflation device 22 related tothe maximum pressure needed to achieve a certain level of inflation.

In certain embodiments, one or more component of catheter proceduresystem 10 (e.g., controller 340) has access to information regarding theparticular type of angioplasty balloon or stent being used to performthe current procedure. Controller 340 may identify the particular typeof inflatable device (e.g., angioplasty balloon or stent) being used ina variety of ways. In one embodiment, the user selects the particulartype of inflatable device being used by interacting with a graphicaluser interface displayed on monitors 304 and/or 306. In one embodiment,the user may select the type of inflatable device used from a drop downmenu. In other embodiments, a bar code on the inflatable device is readto allow controller 340 to identify the inflatable device. In anotherembodiment, a radio frequency ID tag associated with the inflatabledevice is read.

As shown in FIG. 3, controller 340 may also include a data storagemodule 354. Data storage modules discussed herein, such as data storagemodule 354, are configured to support the storage and retrieval ofinformation by the associated controller, such as controller 340. In oneembodiment, a data storage module may be a database for storing patientdata, including image data. In another embodiment, a data storage modulemay be located on hospital network 70. Data storage modules and/orcommunication modules described herein may also be configured to importand/or export patient data from hospital network 70 for use by one ormore of the controllers discussed herein. In one embodiment, controller340 includes an identification and compatibility module 356. Asdiscussed in more detail below, identification and compatibility module356 may be configured to allow controller 340 to identify and controldifferent types (e.g., makes, models, versions, etc.) of devices and/orsystems, such as bedside system 310, that may be communicably coupled tocontroller 340.

FIGS. 4A and 4B show bedside system 310, including a robotic cathetersystem 17 integrated with inflation device 22 according to an exemplaryembodiment. As shown in FIG. 4A, support structure 24 may include aseries of articulating segments attached to and supported by patient bed28. Inflation device 22 includes a pump, shown as plunger 360, and apump drive, shown as motor 362. The output of plunger 360 is connectedto inflation conduit 34 that connects plunger 360 to the internal lumenof the working catheter equipped with the inflatable device.

In operation, plunger 360 is filled with an inflation fluid (e.g.,saline solution, saline/contrast media solution, etc.). Motor 362responds to the manipulation of controls 302 to force fluid from plunger360, through inflation conduit 34 into the internal lumen of the workingcatheter to inflate an inflatable balloon located at the distal end ofthe working catheter. Inflation device 22 includes a pressure sensor,such as pressure transducer 364, located at the output end of plunger360. Pressure transducer 364 reads the pressure generated by plunger360. This information may be communicated via a communication link 38 tocontroller 340.

In one embodiment, catheter procedure system 10 may include additionalcontrols configured to control inflation device 22 located within labunit 12. This may allow a user located within lab unit 12 to controlinflation device 22 during a manually performed percutaneous catheterprocedure (i.e., a procedure in which robotic catheter system 17 is notbeing operated via controls at remote workstation 14 to move the guidewire, guide catheter, working catheter, etc.). In one embodiment, theportion of controls 302 configured to control inflation device 22 mayinclude a wireless device allowing the user to carry the inflationdevice controls into lab unit 12 to control inflation device 22 fromwithin lab unit 12 during a manually performed percutaneous catheterprocedure.

In another embodiment, bedside system 310 may include a connector oradaptor to connect bedside system 310 to a stand alone inflation device.In this embodiment, the inflation device integrated in bedside system310 may be disabled while the stand alone inflation device is connectedto bedside system 310. In this embodiment, the stand alone inflationdevice may be controlled by controls associated with the stand aloneinflation device. However, in another embodiment, integrated controller340 may include software and/or hardware sufficient to allow the user tocontrol the stand alone inflation device via manipulation of controls302 instead of controlling the integrated inflation device 22.

Referring to FIGS. 5-9, in another embodiment, catheter procedure system10 may include separate (i.e., non-integrated) devices for performingcatheter based procedures remotely from workstation 14. In this modularembodiment, various components of catheter procedure system 10 may beconfigured to be easily interchangeable and compatible with componentsof various makes and models. In this embodiment, lab unit 12 includes anon-integrated bedside system 16. In the embodiment of FIG. 5,non-integrated bedside system 16 includes a stand alone robotic cathetersystem 17, a stand alone fluid delivery device, shown as contrast mediadelivery device 20, and a stand alone inflation device 22. Roboticcatheter system 17, contrast media delivery device 20, and inflationdevice 22, are each positioned near patient 18 on separate supportstructures 24, 26, and 32 attached to patient bed 28. In otherembodiments, each support structure 24, 26, and 32 may be a separatestructure, such as a cart or table located near patient 18.

A fluid delivery device, such as contrast media delivery device 20, maybe any device configured to allow a user to administer contrast media topatient 18 during a percutaneous intervention procedure. In otherembodiments, a fluid delivery device may be any device configured toallow a user to administer a fluid (e.g., medicine, saline, etc.) topatient 18 during a percutaneous intervention procedure. For example,the fluid delivery device may be a medication delivery device configureddeliver medicine to a patient. Contrast media conduit 30 connectscontrast media delivery device 20 to one or more of the percutaneousdevices, such as a guide catheter or diagnostic catheter, that bedsidesystem 16 is equipped with. Contrast media delivery device 20 includesvarious components (e.g., pumps, valves, power supplies, contrast mediareservoirs, etc.) to allow contrast media to be administered to thepatient in response to the operation of controls operatively connectedto contrast media delivery device 20.

In one embodiment, robotic catheter system includes a “Y-connector”which is in fluid communication with the lumen of a guide catheter ordiagnostic catheter. In this embodiment, an output end of contrast mediaconduit 30 is connected to the input end of the “Y-connector.” When theuser operates the controls associated with contrast media deliverydevice 20, contrast media delivery device 20 pumps contrast media fromthe contrast media reservoir through contrast media conduit 30 throughthe “Y-connector” into the lumen of the guide or diagnostic catheter.The contrast media then travels through the lumen of the guide ordiagnostic catheter to exit the distal end of the catheter into thedesired position of the patient's vascular system. Contrast media isdelivered to the portion of the patient's vascular system to be imagedto provide increased contrast between the lumen of the blood vessel andthe other structures such as the blood vessel wall or lesions within thevessel. In an embodiment including a medicine delivery device, a conduitmay connect the medicine delivery device to the lumen of the guide ordiagnostic catheter. While not shown, contrast media delivery device 20may be used with the catheter procedure system shown in FIGS. 1-4.

Catheter procedure system 10 also includes a stand alone inflationdevice 22 coupled to a support structure 32. Inflation device 22 may beany device configured to allow a user to inflate an angioplasty balloonor stent during a therapeutic catheterization procedure. As discussedabove, an inflation conduit 34 connects inflation device 22 to one ormore expandable percutaneous devices, such as an angioplasty balloon orstent, that bedside system 16 is equipped with. Inflation device 22includes various components (e.g., pumps, valves, power supplies,inflation media reservoir, etc.) to allow a stent or angioplasty balloonto be inflated in response to the operation of controls operativelyconnected to inflation device 22.

In one embodiment, lab unit 12 includes one or more device to aid in thepositioning and organization of devices within the lab unit 12. In oneembodiment, robotic catheter system 17, contrast media delivery device20, and inflation device 22 are powered by a common power supply locatedwithin lab unit 12. In another embodiment, robotic catheter system 17,contrast media delivery device 20, and inflation device 22 arepositioned on a common cart with wheels that permits the components ofbedside system 16 to be moved within lab unit 12.

Similar to the embodiment of FIGS. 1-4, the components of bedside system16 (e.g., robotic catheter system 17, contrast media delivery device 20,and inflation device 22) are in communication with a remote workstation14, allowing signals generated by user inputs located at workstation 14to be transmitted to the various components of bedside system 16.Bedside system 16 may provide feedback signals (e.g., operatingconditions, warning signals, error codes, etc.) to workstation 14.Bedside system 16 may be connected to workstation 14 via one or morecommunication link 38 that may be a wireless connection, cableconnectors, or any other means capable of allowing communication tooccur between workstation 14 and the devices or systems located withinlab unit 12.

In the embodiment shown in FIG. 5, workstation 14 includes a dedicatedrobotic catheter system user interface 40, a dedicated contrast mediauser interface 42, and a dedicated inflation interface 44. Roboticcatheter system user interface 40, contrast media user interface 42, andinflation interface 44 are positioned on work table 36 withinworkstation 14. In one embodiment, work table 36 is curved to allow theuser to easily move between robotic catheter system user interface 40,contrast media user interface 42, and inflation interface 44. In anotherembodiment, work table 36 comprises two or more tables positioned at anangle relative to each other. In another embodiment, work table 36 is astraight rectangular table. In another embodiment, each user interfacemay be positioned on a movable and/or adjustable work table 36 to allowthe user to position each user interface to suit the user's personalpreference. For example, work table 36 may comprise one or more wheeledcarts, adjustable height tables, adjustable position tables, etc. Inanother embodiment, workstation 14 includes a common power supply topower dedicated robotic catheter system user interface 40, dedicatedcontrast media user interface 42, and dedicated inflation interface 44.

Robotic catheter system user interface 40 includes controls 46. Controls46 allow the user to control robotic catheter system 17 to perform acatheter based medical procedure. For example, controls 46 may beconfigured to cause robotic catheter system 17 to perform various tasksusing the various percutaneous intervention devices with which bedsidesystem 16 may be equipped (e.g., to advance, retract, or rotate a guidewire, advance, retract, or rotate a working catheter, advance, retract,or rotate a guide catheter, advance, retract, or rotate a diagnosticcatheter, etc.). Robotic catheter system user interface 40 may alsoinclude a first monitor 48 and second monitor 50 to display informationas discussed above regarding monitors 304 and 306.

Contrast media user interface 42 includes contrast media controls 52 andcontrast media display 54. Contrast media controls 52 include one ormore buttons or joysticks that allow the user located at workstation 14to instruct contrast media delivery device 20 to deliver contrast mediato patient 18 during a percutaneous procedure. Contrast media controls52 may be configured to allow the user to control various aspects ofcontrast media delivery (e.g., speed or rate of delivery, amount ofcontrast media delivered, timing of delivery, etc.). Contrast mediadisplay 54 is configured to provide various information to the userregarding the delivery of contrast media to patient 18. For example,contrast media display 54 may display the amount of contrast mediadelivered during the current procedure, the type of contrast media beingdelivered, the current rate of delivery, the amount of contrast medialeft in the reservoir of contrast media delivery device 20, etc. In oneembodiment, the amount of contrast media delivered during a specifiedtime period is displayed. This time period may be a set number ofminutes, hours, days, or weeks, etc. The appropriate time period maydepend on the particular type of contrast media used and on theparticular patient. In one embodiment, a user assistance module orsubsystem, such as user assistance module 358, may be configured toalert the user when the amount of contrast agent delivered reaches acertain predetermined value (e.g., a maximum amount for the specifiedperiod of time, etc.).

Inflation interface 44 includes inflation controls 56 and inflationdisplay 58. Inflation controls 56 include one or more buttons orjoysticks that allow the user located at workstation 14 to instructinflation device 22 to inflate (e.g., expand, deploy, etc.) and/ordeflate an inflatable percutaneous intervention device, such as a stentor angioplasty balloon, during a percutaneous procedure. Inflationcontrols 52 may be configured to allow the user to control variousaspects of balloon or stent inflation and/or deflation (e.g., rate ofinflation, extent of inflation, amount of time the balloon or stentremains inflated, etc.). Inflation display 58 is configured to providevarious information to the user of workstation 14 regarding the state ofan expandable percutaneous intervention device. For example, inflationdisplay 58 may display an image of the balloon or stent within thepatient, an indication of whether bedside system 16 is currentlyequipped with an angioplasty balloon or a stent, information about thetype of device being used (e.g., the size, shape, manufacturer, etc.),information about the extent of inflation of the balloon or stent, theduration of inflation, the amount of force being exerted on the balloonor stent by the vessel wall, etc. Catheter procedure system 10 may alsoinclude an imaging system 60 as discussed above.

Referring to FIG. 6, a block diagram of catheter procedure system 10 isshown according to an exemplary embodiment. In this embodiment, eachstand alone component of bedside system 16 directly communicates with adedicated control system. For example, catheter procedure system 10 mayinclude a first control system, shown as catheter controller 62.Controller 62 is in communication with one or more robotic cathetersystems 17, catheter controls 46, monitors 48 and 50, imaging system 60,and patient sensors 68. In addition, controller 62 may be incommunication with a hospital data management system or hospital network70, one or more additional output devices 72 (e.g., printer, disk drive,cd/dvd writer, etc.), and a hospital inventory management system 74.

In addition, catheter procedure system 10 includes a second controlsystem, shown as contrast media controller 64 and a third controlsystem, shown as inflation controller 66. Contrast media controller 64is in communication with one or more contrast media delivery devices 20,contrast media display 54, and contrast media controls 52. Inflationcontroller 66 is in communication with inflation device 22, inflationdisplay 58, and inflation controls 56. In one embodiment, controllers62, 64, and 66 may also be communicably coupled to each other allowingfor the transfer of information between each of the dedicatedcontrollers 62, 64, and 66. As discussed above, communication betweenthe various components of catheter procedure system 10 may beaccomplished via communication links 38.

Referring to FIGS. 7-9, block diagrams of controller 62, controller 64,and controller 66 are shown according to exemplary embodiments.Controllers 62, 64, and 66 may generally be an electronic control unitsuitable to provide catheter procedure system 10 with the variousfunctionalities described herein. For example, controllers 62, 64, and66 may be embedded systems, dedicated circuits, general purpose systemsprogrammed with the functionality described herein, etc.

Controller 62 includes a processing circuit 76, memory 78, communicationmodule or subsystem 80, communication interface 82, catheter systemcontrol module or subsystem 84, a compatibility module 86, a datastorage module 88, and a user assistance module 89. Controller 62 mayinclude additional modules or subsystems such as those described indescribed in detail in International Application No. PCT/US2009/55320,filed Aug. 28, 2009, and International Application No. PCT/US2009/55318,filed Aug. 28, 2009, both of which are incorporated herein by referencein their entireties. Referring to FIG. 8, contrast media controller 64includes a process circuit 100, memory 102, communication module 104,communication interface 106, compatibility module or subsystem 108,contrast media delivery device control module or subsystem 110, and auser assistance module or subsystem 112. Referring to FIG. 9, inflationcontroller 66 includes a process circuit 120, memory 122, communicationmodule 124, communication interface 126, compatibility module orsubsystem 128, inflation device control module or subsystem 130, and auser assistance module or subsystem 132.

Similar to catheter system control module 350, catheter system controlmodule 84 is configured to support the control of robotic cathetersystem 17 during a catheter based medical procedure. Catheter systemcontrol module 84 allows the manipulation of catheter controls 46 by theuser to operate robotic catheter system 17. Catheter system controlmodule 84 may also cause data appropriate for a particular procedure tobe displayed on monitors 48 and 50. In addition, procedure controlmodule 84 may also be configured to allow a user located at workstation14 to operate imaging system 60.

Contrast media controller 64 includes a contrast media delivery devicecontrol module 110 configured to support the control of contrast mediadelivery device 20 during a catheter based medical procedure. Contrastmedia delivery device control module 110 allows manipulation of controls52 by the user to operate contrast media delivery device 20. Contrastmedia delivery device control module 110 may also cause data appropriatefor a particular procedure to be displayed on monitor 54 during aprocedure.

Inflation controller 66 includes an inflation device control module 130configured to support the control of inflation device 22 during acatheter based medical procedure. Similar to inflation device controlmodule 352, inflation device control module 130 allows manipulation ofcontrols 56 by the user to operate inflation device 22. Inflation devicecontrol module 130 may also cause data appropriate for a particularprocedure to be displayed on monitor 58 during a procedure.

FIGS. 5-9 illustrate a modular embodiment of catheter procedure system10. In this embodiment, catheter controller 62 may be connected tocontrollers 64 and 66 via communication links 38 to facilitatecommunication and exchange of data between the controllers 62, 64, and66. In this embodiment, data accessible to procedure controller 62(e.g., patient information archived on hospital network 70, data frompatient sensors 68, data from imaging system 60, positional informationof percutaneous devices, etc.) may be shared with contrast mediacontroller 64 and/or inflation controller 66. This data may then beprocessed or displayed by controllers 64 and/or 66. In addition, dataaccessible to contrast media controller 64 (e.g., flow rate of contrastmedia, amount of contrast media delivered, etc.) and/or data accessibleto inflation controller 66 (e.g., extent of stent/balloon inflation,rate of stent/balloon inflation, etc.) may be shared with cathetercontroller 62. This data may then be processed or displayed bycontroller 62. For example, data transferred from contrast mediacontroller 64 and/or inflation controller 66 may be displayed on monitor48 and/or monitor 50 associated with controller 62 instead of or inaddition to display of this information on monitors 54 and 58. In thisembodiment, controller 62 may be configured to provide a standardizedvisual display of information related to each of robotic catheter system17, contrast media delivery device 20, and/or inflation device 22.

In one embodiment, catheter controller 62 is configured to act as aserver or host to one or more controllers 64 and 66 in a server/clientrelationship. In another embodiment, procedure controller 62 includes adata storage module 88 that is configured to support the storage andretrieval of information by controller 62. In one embodiment, datastorage module 88 is a database for storing patient data, includingimage data. In another embodiment, data storage module 88 may be locatedon hospital network 70. Data storage module 88 and/or communicationmodule 80 may also be configured to import and/or export patient datafrom hospital network 70 for use by controller 62. Communication links38 between controllers 62, 64, and 66 may allow data stored by datastorage module 88 to be transferred or accessed by controllers 64 and66. In addition, data transferred to controller 62 from controllers 64and 66 may be stored within data storage module 88.

In this embodiment, the data from controllers 62, 64, and 66 may beassociated with a particular file or record for a particular patient. Inone embodiment, data from controllers 62, 64, and 66 may be aggregatedto generate a combined report to show the operation of each of the standalone components of bedside system 16 during a particular procedure. Forexample, the combined report may show graphs representing the movementof the guide wire, guide catheter, and working catheter at various timepoints during the procedure. This graph may also show operation ofcontrast media delivery device 20 and inflation device 22 at these sametimes. In one embodiment, a single graph may be generated showing theamount of contrast media delivered vs. time, the fluid pressuregenerated by inflation device 22 vs. time, and the movement of apercutaneous device vs. time.

In another embodiment, controller 62 may be linked directly to contrastmedia delivery device 20 and/or inflation device 22 via one or morecommunication links 38 instead of or in addition to being connected tocontrollers 64 and 66. In this case, information related to contrastmedia delivery device 20 (e.g., flow rate of contrast media, amount ofcontrast media delivered, etc.) and/or inflation device 22 (e.g., extentof stent/balloon inflation, rate of stent/balloon inflation, etc.) maybe communicated directly to controller 62. In this case, the data may bestored, processed, displayed, etc. as discussed herein.

Further, in the modular embodiment, communication links 38 betweenprocedure controller 62, media controller 64, and/or inflationcontroller 66 are configured to be easy to establish and to disconnectto allow for convenient removal/addition of the various modularcomponents. For example, procedure controller 62 may be compatible withmany different types (e.g., versions, makes, models, etc.) of contrastmedia controllers 64 and/or inflation controllers 66. In this case, thecommunication interfaces of controllers 62, 64, and 66 include easilyaccessible ports or jacks to allow the user to easily attach theappropriate cables between controllers 62, 64, and 66 to act ascommunication links 38 between these devices. In another embodiment, thecommunication modules and/or communication interfaces may includesoftware and/or hardware to facilitate the convenient establishment ofwireless communication links between controllers 62, 64, and 66. Inother embodiments, the communication interfaces associated withcontrollers 62, 64, and 66 may be standard communication interfaces(e.g., USB, firewire, Bluetooth, etc.). In other embodiments, thecommunication interfaces associated with controllers 62, 64, and 66 maybe proprietary.

In addition, catheter controller 62 may include an identification andcompatibility module 86. Compatibility module 86 allows cathetercontroller 62 to identify the particular contrast media controller 64and/or inflation controller 66 to which catheter controller 62 has beenconnected. Following identification, compatibility module 86 activatesthe proper software, hardware, drivers, etc. to allow cathetercontroller 62 to communicate with contrast media controller 64 and/orinflation controller 66.

In another embodiment, shown in FIG. 10, catheter procedure system 10may include a communication hub 90. Controllers 62, 64, and 66 androbotic catheter device 17, contrast media delivery device 20, andinflation device 22 may be communicably coupled to communication hub 90via communication links 38. In this embodiment, communication hub 90includes one or more communication interfaces for establishingconnection to communication links 38. Communication hub 90 includessoftware and/or hardware to facilitate communication between controllers62, 64, 66, robotic catheter device 17, contrast media delivery device20, and inflation device 22. Communication hub 90 may provide a singlecommunication unit able to facilitate communication between controllers62, 64, and 66, robotic catheter device 17, contrast media deliverydevice 20, and inflation device 22 of different makes, models, etc. Inone embodiment, communication hub 90 includes an identification andcompatibility module, such as module 86, discussed above. Further, asshown in FIG. 10, communication hub 90 may also be configured tofacilitate communication between controllers 62, 64, and 66 and theimaging system 60, patient sensors 68, hospital network 70, and hospitalinventory system 74 via communication links 38. In another embodiment,the monitors, controls, and additional output devices associated witheach controller may communicate through communication hub 90 viacommunication links 38.

In another embodiment shown in FIGS. 11-13, procedure control system 10may include a single, integrated user interface 200 located withinworkstation 14, an integrated control system, shown as integratedcontroller 206, and an integrated bedside system 250. Integrated bedsidesystem 250 integrates robotic catheter system 17, contrast mediadelivery device 20, and inflation device 22 into a single unit. As shownin FIG. 11, integrated bedside system 250 utilizes a single support 24.In addition, integrated bedside system 250 may include a single powersupply for robotic catheter system 17, contrast media delivery device20, and inflation device 22. In addition, integrated bedside system 250may communicate to integrated controller 206 via a single communicationlink 38.

Integrated user interface 200 and integrated controller 206 provide allof the functionality discussed above regarding interfaces 40, 42, 44,and controllers 62, 64, and 66, respectively. Integrated user interface200 includes integrated controls 202 and integrated display 204.Integrated controls 202 may include one or more buttons or joysticks, orsets of buttons or joysticks configured to control robotic cathetersystem 17, contrast media delivery device 20, and inflation device 22 ofintegrated bedside system 250. In one embodiment, integrated controls202 includes dedicated controls 230, 232, and 234, assigned to controlrobotic catheter system 17, contrast media delivery device 20, andinflation device 22, of integrated bedside system 250 respectively. Inone embodiment, dedicated controls 230, 232, and 234 may be assigned bythe user to control robotic catheter system 17, contrast media deliverydevice 20, or inflation device 22 as desired by the user. In anotherembodiment, integrated controller 206 may include a single joystickhaving multiple switches, buttons, tabs, etc., located such that theuser may control robotic catheter system 17, contrast media deliverydevice 20, and/or inflation device 22 with a single hand. In thisembodiment, the user's other hand may be free to perform other tasks,such as controlling imaging system 60, interacting with information(e.g., zooming in, highlighting, etc.) displayed on monitor 204, etc.

Integrated monitor 204 is configured to display all information for aparticular procedure, including information related to robotic cathetersystem 17, to contrast media delivery device 20, and/or to inflationdevice 22, on a single display device. In one embodiment, integratedmonitor 204 includes different areas reserved to display informationrelated to each of the devices to which integrated controller 206 isconnected. In another embodiment, integrated monitor 204 may beconfigured to provide a standardized visual display of informationrelated to each of robotic catheter system 17, contrast media deliverydevice 20, or inflation device 22.

In another embodiment, integrated bedside system 250 may be operated viathe distributed or modular user interfaces 40, 42, 44 and controlled viathe distributed or modular controllers 62, 64, and 66. In anotherembodiment, a portion of integrated bedside system 250 (e.g., onlyrobotic catheter system 17, only contrast delivery device 20, onlyrobotic catheter system 17 and contrast delivery device 20, etc.) may becontrolled and operated by integrated controller 206 and operated viaintegrated user interface 200, and the other components may becontrolled and operated via the corresponding dedicated controller anduser interface.

In addition, as shown in FIG. 13, integrated controller 206, includes aintegrated processor 210, integrated memory 212, integratedcommunication module 214, integrated communication interface 216,catheter control module 218, identification and compatibility module220, contrast media delivery device control module 222, inflation devicecontrol module 224, data storage module 226, and user assistance module228. Integrated communication module 214, integrated communicationinterface 216, catheter control module 218, identification andcompatibility module 220, contrast media delivery device control module222, inflation device control module 224, data storage module 226, anduser assistance module 228 are configured to provide the functionalitydiscussed above regarding controllers 62, 64, 66, and/or 340. However,in the embodiment shown, integrated controller 206 provides thisfunctionality while reducing redundant components by utilizing a commonprocessor 210, common memory 212, and a common communication interface216.

In one embodiment shown in FIG. 14, integrated controller 206 is indirect communication with a stand alone robotic catheter system 17, astand alone contrast media delivery device 20, and a stand aloneinflation device 22. Compatibility module 220 allows integratedcontroller 206 to control different types (e.g., versions, makes,models, etc.) of robotic catheter systems 17, contrast media deliverydevices 20 and/or inflation devices 22. Compatibility module 220identifies the robotic catheter system 17, contrast media deliverydevice 20 and/or inflation device 22 to which integrated controller 206has been connected. Following identification, compatibility module 220activates the proper software, hardware, drivers, etc. to allowintegrated controller 206 to communicate with and/or control theparticular robotic catheter systems 17, contrast media delivery device20, and/or inflation device 22.

In this embodiment, contrast media delivery device control module 222allows manipulation of integrated controls 202 by the user to operatecontrast media delivery device 20. Contrast media delivery devicecontrol module 222 may also cause data appropriate for a particularprocedure to be displayed on integrated monitor 204 during a procedure.Inflation device control module 224 allows manipulation of integratedcontrols 202 by the user to operate inflation device 22. Inflationdevice control module 224 may also cause data appropriate for aparticular procedure to be displayed on integrated monitor 204 during aprocedure.

In another embodiment shown in FIG. 15, integrated controller 206includes a module to allow integrated controller 206 to communicate witha stand alone contrast media controller, such as controller 64, and/orwith a stand alone inflation controller 66. This embodiment allowsintegrated controller 206 to function as discussed above regardingcontroller 62. In this embodiment, integrated controller 206 controlsvarious components of procedure system 10, such as imaging system 60 androbotic catheter system 17, via catheter control module 218. However, inthis embodiment, the stand alone contrast media controller 64 and/or thestand alone inflation controller 66 directly control contrast mediadelivery device 20 and inflation device 22.

In this embodiment, integrated controller 206 is configured to detectwhether integrated controller 206 is connected directly to contrastmedia device 20 and/or inflation device 22 or is connected directly to astand alone contrast media controller 64 and/or the stand aloneinflation controller 66. If integrated controller 206 is connecteddirectly to contrast media device 20 and/or inflation device 22, thecontrast media delivery device control module 222 and/or inflationdevice control module 224 is active to control the devices 20 and 22. Ifintegrated controller 206 is connected directly to a stand alonecontrast media controller 64 and/or the stand alone inflation controller66, the contrast media delivery device control module 222 and/orinflation device control module 224 are inactive allowing the standalone controllers to control each device. In one embodiment, integratedcontroller 206 is configured to allow the user to decide whetherintegrated controller 206 will directly control contrast media device 20and/or inflation device 22 even if integrated controller 206 isconnected to stand alone contrast media controller 64 and/or the standalone inflation controller 66.

As shown in FIG. 15, in an embodiment in which integrated controller 206is connected to a stand alone contrast media controller 64 and/or astand alone inflation controller 66, integrated controller 206 may beconfigured to allow a user to assign controls 230, 232, and 234 ofintegrated controls 202 to control contrast media delivery device 20and/or inflation device 22 as opposed to having the controls (e.g.,controls 52, and 56) associated with stand alone contrast mediacontroller 64 and/or a stand alone inflation controller 66 control thosedevices. This allows the particular user to use the set of controls(e.g., integrated controls 202 or dedicated controls 52 or 56) that theuser prefers. This may also provide redundancy in the event that one setof controls breaks or malfunctions.

The exemplary embodiments illustrated in the figures and describedherein are offered by way of example only. Accordingly, the presentapplication is not limited to a particular embodiment, but extends tovarious modifications that nevertheless fall within the scope of theappended claims. In addition, any of the embodiments described hereinmay incorporate features, elements, modules, subsystems, functionality,etc. of any other exemplary embodiment.

The construction and arrangement of the systems and methods as shown inthe various exemplary embodiments are illustrative only. Any of thefeatures, elements, or components of any of the exemplary embodimentsdiscussed above may be used alone or in combination with any of thefeatures, elements, or components of any of the other embodimentsdiscussed above. Although only a few embodiments have been described indetail in this disclosure, many modifications are possible (e.g.,variations in sizes, dimensions, structures, shapes and proportions ofthe various elements, values of parameters, mounting arrangements, useof materials, colors, orientations, etc.). For example, the position ofelements may be reversed or otherwise varied and the nature or number ofdiscrete elements or positions may be altered or varied. All suchmodifications are intended to be included within the scope of thepresent disclosure. Software implementations could be accomplished withstandard programming techniques with rule based logic and other logic toaccomplish the various connection steps, processing steps, comparisonsteps and decision steps. Other substitutions, modifications, changes,and omissions may be made in the design, operating conditions andarrangement of the exemplary embodiments without departing from thescope of the present disclosure.

1-35. (canceled)
 36. A catheter procedure system comprising: a bedsidesystem, the bedside system comprising: a catheter including anexpandable percutaneous intervention device; a robotic catheter systemconfigured to move the catheter; and an inflation device configured tocause expansion of the expandable percutaneous intervention device; anda remote workstation, the remote workstation comprising: a userinterface configured to receive at least a first user input and a seconduser input; a control system operatively coupled to the user interfacefor remotely controlling both the robotic catheter system and theinflation device; and a monitor configured to display informationrelated to the expandable percutaneous intervention device; wherein thecontrol system controls the robotic catheter system to move the catheterbased upon at least the first user input and controls the inflationdevice to cause expansion of the expandable percutaneous interventiondevice based upon at least the second user input, and wherein thecontrol system is configured to prevent, slow or stop expansion of theinflation device when a target point of the inflation device is notaligned with a landmark.
 37. The catheter procedure system of claim 36,wherein the control system is configured to position the landmark over areal time image of a lesion to identify an optimal position of theinflation device relative to the lesion and to automatically causeexpansion of the expandable percutaneous intervention device at apredetermined rate based on an inflation profile.
 38. A remoteworkstation configured for operating both a robotic catheter system andan inflation device, the remote workstation comprising: a user interfaceconfigured to receive at least a first user input and a second userinput; a control system to control the robotic catheter system to moveat least one percutaneous device based upon at least the first userinput and to control the inflation device to expand an expandablepercutaneous intervention device based upon at least the second userinput; and a user assistance subsystem operatively connected to thecontrol system configured to provide information to the user to assistthe user in the use of the expandable percutaneous intervention device,wherein the user assistance subsystem is configured to alter control ofthe fluid delivery device based upon the movement of the at least onepercutaneous device in order to synchronize the delivery of fluid withthe movement of the at least one percutaneous device.
 39. A catheterprocedure system comprising: a bedside system, the bedside systemcomprising: a catheter, the catheter including an internal lumen and anexpandable percutaneous intervention device; a support structureconfigured to be coupled to a patient bed; a robotic catheter systemcoupled to the support structure and configured to move the catheter; aninflation device coupled to the support structure and configured tocause expansion of the expandable percutaneous intervention device; andan inflation conduit connecting the inflation device to the internallumen of the catheter; an imaging system to capture images of thecatheter; and a remote workstation, the remote workstation comprising: amonitor; controls configured to receive at least a first user input andat least a second user input; and a control system operatively coupledto the controls for remotely controlling the robotic catheter system,the inflation device and the imaging system; wherein the control systemcontrols the robotic catheter system to move the catheter based upon atleast the first user input and controls the inflation device to cause afluid to flow from the inflation device through the inflation conduitinto a lumen of the catheter to cause expansion of the expandablepercutaneous intervention device based upon at least the second userinput, and further wherein the monitor displays information related toboth the robotic catheter system and the inflation device, and whereinthe control system is configured to cause the imaging system to captureimages at times associated with stages of inflation of the inflationdevice.
 40. The catheter procedure system of claim 39, wherein thecontrol system is configured to cause the imaging system to captureimages at times associated with predetermined percentage inflation. 41.The catheter procedure system of claim 40, wherein the control system isconfigured to cause the imaging system to capture images at timesassociated with one percent inflation, fifty percent inflation andone-hundred percent inflation.